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Two Independent Peer-Reviewed Studies Validate Cernostics’ TissueCypher® Barrett’s Esophagus Assay (TissueCypher®) to Accurately Predict Progression to Esophageal Cancer in Patients with Barrett’s Esophagus

On November 18, 2020 Cernostics, Inc. the GI Precision Medicine company, reported two newly completed clinical studies confirming the ability of the TissueCypher Barrett’s Esophagus Assay to identify patients at high risk for progression to cancer (Press release, Cernostics, NOV 18, 2020, View Source [SID1234571324]). The two independent peer-reviewed studies, both authored by Prof. Jacques Bergman and Dr. Nicola Frei (University Medical Center, Amsterdam, the Netherlands), have further validated Cernostics’ TissueCypher Barrett’s Esophagus Assay to accurately and objectively predict which patients with Barrett’s esophagus will develop esophageal cancer. These studies confirm the accuracy of the assay in patients with NDBE and LGDBE, and support clinical adoption of the assay to help providers make better-informed clinical decisions. TissueCypher has the potential to improve patient care by identifying patients at high risk for development of esophageal cancer who will benefit from early intervention or increased surveillance, as well as identifying patients at low risk for progression who can avoid unnecessary procedures.

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• Independent Validation of TissueCypher to Predict Future Progression in Non-Dysplastic Barrett’s Esophagus: A Spatial-Temporal Analysis, published in Clinical and Translational Gastroenterology. This blinded independent validation study confirms the ability of TissueCypher to accurately predict incident/future progression to esophageal cancer in patients with NDBE. The study also demonstrated that sampling multiple endoscopic levels across the Barrett’s segment further increases the detection rate for NDBE patients at high-risk for incident progression to esophageal cancer. This study validated findings from previous studies that TissueCypher identifies a high-risk subset of patients with NDBE who progress at a rate that is higher than published estimates for expert pathologist-confirmed LGD. A TissueCypher high-risk score in patients with NDBE may support a management approach similar to the approach for confirmed LGD, which includes endoscopic eradication therapy or increased surveillance to prevent development of cancer. This is a crucial finding as these are the "at-risk" group who may be missed by the current standard of care. This is the fourth study to independently validate the TissueCypher assay, and provides a critical level of evidence to support clinical adoption of the assay to risk stratify patients with non-dysplastic BE.

• Tissue Systems Pathology Test Objectively Risk Stratifies Barrett’s Esophagus Patients with Low-Grade Dysplasia, accepted in American Journal of Gastroenterology This blinded cohort study evaluated the TissueCypher Barrett’s Esophagus Assay in the screening cohort of a randomized controlled trial of SUveillance versus RadioFrequency ablation (SURF) for BE patients with community-based diagnosis of LGD. This is the fifth study to independently validate the risk stratification of TissueCypher, and a key strength is the study design in which the cohort was prospectively enrolled and followed. The results independently validated the ability of TissueCypher to objectively risk-stratify patients with LGD. TissueCypher provided objective risk stratification, whereas there was significant variability between the expert pathologists whose diagnoses were concordant for only 51.7% of cases in this study. In addition to risk stratifying patients with expert pathologist-confirmed LGD, TissueCypher also identified approximately 50% of the progressors that were downstaged to NDBE by expert pathologists. These patients are a high-risk subset who may be missed by the current standard of care, but could be identified early by TissueCypher and undergo management similar to LGD to prevent progression to cancer.

"Key opinion leaders from around the world continue to validate the potential for TissueCypher to improve care for patients with Barrett’s esophagus," commented Cernostics CEO Mike Hoerres. "We appreciate Prof. Jacques Bergman’s continued commitment to evaluating our innovative technology, and we anticipate additional studies from thought-leading institutions in the coming months that further validate the unique ability of TissueCypher to predict progression in patients with BE. Our momentum in growing clinical evidence and adoption bodes well for patients afflicted with this disease state and their physicians."

About Barrett’s Esophagus and TissueCypher

Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, BE can lead to esophageal adenocarcinoma, the fastest-rising cancer in the U.S. The current approach to managing BE is surveillance, involving regular endoscopic procedures with biopsies, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus. Cernostics has developed and commercialized the world’s first precision medicine test that predicts risk of developing esophageal cancer in patients with Barrett’s esophagus. The patent-protected technology platform – TissueCypher Barrett’s Esophagus Assay – uniquely analyzes whole slide digital images with multiplexed fluorescence, providing greater information and accuracy than traditional subjective tissue diagnostics. TissueCypher provides actionable information to gastroenterologists, eliminating the uncertainty related to the management of Barrett’s esophagus patients.

Foundation Medicine Enters into Patent Licensing and Technology Agreement with TwinStrand Biosciences

On November 18, 2020 Foundation Medicine reported it has entered into a non-exclusive agreement to license two foundational patent families from TwinStrand Biosciences, a next-generation DNA sequencing technology company based in Seattle (Press release, Foundation Medicine, NOV 18, 2020, View Source [SID1234571357]).

The patented TwinStrand Duplex Sequencing technology is a biochemistry- and software-based platform that enables researchers and clinicians to detect faint signals of ultra-low frequency DNA mutations often obscured by technical noise.

"Advancing and improving patient care is our highest priority and we’re pleased to work with partners like TwinStrand who share this same goal," said Cindy Perettie, Foundation Medicine’s chief executive officer. "We look forward to expanding this agreement with TwinStrand to explore additional areas for future collaboration."

"We are delighted to partner with Foundation Medicine, a company that shares our patient-centric mission of applying innovative science to advance cancer care globally," said Jesse Salk, MD, PhD, TwinStrand’s chief executive officer. "We are excited to help power Foundation Medicine’s commitment to delivering the highest quality data and genomic insights to physicians and their patients."

QBiotics’ STELFONTA® Receives FDA Approval for Canine Mast cell Tumours

On November 18, 2020 QBiotics Group Limited (QBiotics), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that the U.S. Food and Drug Administration’s (U.S. FDA) Center for Veterinary Medicine (CVM) has approved its lead veterinary anticancer product, STELFONTA, making it the first FDA approved treatment for all grades of canine non-metastatic mast cell tumours (Press release, QBiotics, NOV 18, 2020, View Source [SID1234571378]). The news follows approvals for STELFONTA in early 2020 by the European Medicines Agency (EMA), the United Kingdoms’s Veterinary Medicines Directorate (VMD), and Swissmedic, with subsequent sales in all major European markets.

In the United States, STELFONTA (tigilanol tiglate injection) is indicated for the treatment of all non-metastatic cutaneous MCT and non-metastatic subcutaneous MCT, located at or distal to the elbow or the hock in dogs. MCTs are the most frequently diagnosed cancer in dogs, accounting for up to 21% of skin cancer cases[3].

Dr Chad Johannes, Assistant Professor of Oncology at Iowa State University, and consultant to QBiotics commented, "STELFONTA brings a novel therapeutic mechanism and intratumoural delivery route to veterinary medicine. The efficacy and durability of response data in dogs with mast cell tumours are very promising. While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways."

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, "FDA approval is a pivotal achievement for both STELFONTA and QBiotics. STELFONTA has the potential to be a category igniter – given it is easy to administer, provides 75% complete tumour resolution after just one injection, and dogs quickly regain pre-treatment quality of life. European sales of STELFONTA have been impressive, and we are excited to be working with Virbac to bring the drug to the US market to help treat the 3 million dogs there that each year are diagnosed with cancer."

Dr Gordon continued, "this approval also provides strong validation of our highly efficient business model, where veterinary product sales provide repeatable revenue for the company, and the strong veterinary data underpins our human drug development programme. Clinical efficacy and safety responses reported in canine patients are also being mirrored in our human patients. In a Phase I/IIa human safety trial, tigilanol tiglate, the active ingredient in STELFONTA, demonstrated antitumour responses in a range of solid tumours. This included complete responses (where the tumour is completely destroyed) in head and neck squamous cell carcinoma and melanoma. Notably, a maximum tolerated dose was not declared for this study. We are currently investigating the drug’s potential as both a monotherapy and an immune checkpoint inhibitor combination therapy through a series of Phase II clinical trials."

Tigilanol tiglate is a small molecule that largely acts through specific protein kinase C (PKC) activation[4], leading to rapid destruction of the tumour mass and the tumour’s blood supply, as well as stimulation of the immune system. Tumour destruction is followed by rapid healing of the site with minimal scarring.

QBiotics and its partner, Virbac, a global animal health company, will first launch STELFONTA to specialist U.S. veterinary oncologists over the coming months, followed by the launch to primary care veterinarians in early 2021.

Cellaria Inc. partners with researchers at Northeastern University to advance new photomedicine therapies for key cancers

On November 18, 2020 Cellaria Inc (Wakefield, MA, USA) and the Spring Lab, Northeastern University, reported the successful receipt of a National Institutes of Health (NIH) R01 grant to extend and advance the application of innovative new photomedicine-based therapies for hard-to-treat cancers (Press release, Cellaria, NOV 18, 2020, View Source [SID1234571325]). The grant highlights the close working relationship of the two organizations and will provide $3.2M funding to develop precision therapeutics closely tailored to the requirements of specific patient populations. Cellaria’s contribution to the partnership is next generation, patient-derived, customized cell models that boost the effectiveness of in vitro studies, helping researchers to identify where the technology can have the most impact. Dr Bryan Spring, Assistant Professor of Biomedical Physics credits Cellaria with a vital role in accelerating his research.

"We’ve demonstrated proof of concept and seen significant interest from clinicians," said Dr Spring. "However, we initially targeted just a single ovarian cancer biomarker. To capture the heterogeneity of the disease and efficiently study multiple biomarkers we needed to upgrade our cell models. Developing new models in-house would have taken years and instead we chose to work with Cellaria. This has really accelerated progress by providing rapid access to rigorously characterized cell models for specific molecular subtypes and patient populations."

Dr Spring’s research focuses on the use of antibody-photosensitizer conjugates to make cancer cells susceptible to light-induced destruction, targeting microscopic cancer cell deposits left behind by conventional therapies. Primary areas of application are pancreatic and ovarian cancer. With these cancers, cells left behind by surgery and other conventional therapies can metastasize in the peritoneal cavity and abdomen, attacking other organs and increasing the severity of the disease. The new NIH research grant is entitled "Multiplexed and dynamically targeted photoimmunotherapy of heterogeneous, chemoresistant micrometastases guided by online in vivo optical imaging of cell-surface biomarkers".

Cellaria provides cell models, complete with comprehensive omics data, that help the researchers to determine which biomarkers are most actionable when it comes to targeting drug resistant cells and applying the photomedicine. These cell models robustly represent the full heterogeneity of the cancers, which is essential for the development of precision therapies. Dr Spring has been using Powder, a high grade serous ovarian cancer cell model developed from the carcinoma of a 65 – 69 Caucasian, stage IV patient. New models for pancreatic cancer have recently been added to the Cellaria portfolio. All have a robustly authenticated lineage and are provided with protocols to maintain specific biomarker expression. Cellaria’s unrivalled expertise in cell line growth, stabilization and characterization underpin the company’s ability to supply customised models that enable researchers to identify the specific biomarkers of most relevance to their work.

"Cellaria have all the -omics in place and are highly responsive in terms of refining models to our requirements," said Dr Spring. "The Cellaria team are experts in their field and great to work with. The bottom line is that via this collaboration we get to concentrate on our science, rather than the tools we need to support it, which is just as we prefer it."

Personalis, Inc. to Present at EACR Liquid Biopsies Virtual Event

On November 18, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported that the company will participate in the EACR Liquid Biopsies Virtual Event, November 18-19, including a poster presentation and satellite symposia (Press release, Personalis, NOV 18, 2020, View Source [SID1234571358]).

The company will showcase both their platforms, ImmunoID NeXT and NeXT Liquid Biopsy.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample, thus maximizing the biological information that can be generated from a precious tumor specimen.

NeXT Liquid Biopsy, a first-of-its-kind, high-performance exome-wide liquid biopsy assay, provides a unique ability to evaluate the cancer ecosystem and advance the development of next-generation therapies. While solid tumor biopsies remain the standard for the interrogation of the cancer genome, the advent of liquid biopsies has demonstrated there can be more to a cancer’s genotypic profile than that found in a single tissue biopsy. Therefore, the combination of NeXT Liquid Biopsy and ImmunoID NeXT delivers the most comprehensive view of a cancer’s mutational landscape by evaluating both the tissue and blood. NeXT Liquid Biopsy enables investigation into key applications such as spatial and temporal heterogeneity of the tumor, clonal evolution and tumor dynamics in response to therapies, and mechanisms of acquired resistance. In this presentation, we’ll highlight data demonstrating the genomic profiling and assay performance enabled by NeXT Liquid Biopsy through the evaluation of reference standards and patient samples.

Following are details for the Personalis presentations.

Scientific Poster Presentation

Poster Number

Title & Presenter

Dates

Sensitive detection and monitoring of genetic alterations in circulating cfDNA with an enhanced whole-exome approach
Presenter: Simo V. Zhang, PhD

NOV 18-19 | Online

Following are details of an industry-sponsored symposium which will be presented at the meeting.

Satellite Symposia

Title